Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)
Hikma Pharmaceuticals USA Inc.
LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg in 1 mL
EPIDURAL
PRESCRIPTION DRUG
Lidocaine HCl Injections are indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed. Lidocaine HCl is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.
Lidocaine Hydrochloride Injection, USP is available as: Preservative-Free 1% (50 mg/5 mL) (10 mg/ mL) 5 mL Single Dose Vials packaged in 25s (NDC 0143-9595-25) 2% (100 mg/5 mL) (20 mg/ mL) 5 mL Single Dose Vials packaged in 25s (NDC 0143-9594-25) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . For Product Inquiry call 1-877-845-0689.
Abbreviated New Drug Application
LIDOCAINE HYDROCHLORIDE- LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION HIKMA PHARMACEUTICALS USA INC. ---------- LIDOCAINE HYDROCHLORIDE INJECTION, USP PRES ERVATIVE-FREE FOR INFILTRATION AND NERVE BLOCK RX ONLY DESCRIPTION Lidocaine Hydrochloride Injections are sterile, nonpyrogenic, aqueous, isotonic solutions that contain a local anesthetic agent and are administered parenterally by injection. See INDICATIONS AND USAGE for specific uses. Each mL of the 1% solution contains lidocaine hydrochloride 10 mg and sodium chloride 7 mg. Each mL of the 2% solution contains lidocaine hydrochloride 20 mg and sodium chloride 6 mg. The pH of these solutions is adjusted to approximately 5.0 to 7.0 with sodium hydroxide and/or hydrochloric acid. Lidocaine Hydrochloride Injection solutions contain lidocaine hydrochloride which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular wt. 270.8. Lidocaine HCl (C H N O • HCl) has the following structural formula: CLINICAL PHARMACOLOGY MECHANISM OF ACTION Lidocaine HCl stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses thereby effecting local anesthetic action. HEMODYNAMICS Excessive blood levels may cause changes in cardiac output, total peripheral resistance, and mean arterial pressure. With central neural blockade these changes may be attributable to block of autonomic fibers, a direct depressant effect of the local anesthetic agent on various components of the cardiovascular system, and/or the beta-adrenergic receptor stimulating action of epinephrine when present. The net effect is normally a modest hypotension when the recommended dosages are not exceeded. PHARMACOKINETICS AND METABOLISM Information derived from diverse formulations, concentrations and usages reveals that lidocaine HCl is 14 22 2 completely absorbed following parenteral administration, its rate of absorption depending, for example, upon various factors such as the site of admini Lugege kogu dokumenti